A Validation Study for Detecting Chlamydia and Gonorrhea in Rectal Samples
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Purpose
Our hypothesis is that nucleic acid amplification testing (NAAT) with the APTIMA Combo2 (AC2) will have greater sensitivity than culture in detecting Neisseria gonorrhoeae in rectal samples. We also hypothesize that AC2 will be equivalent to NAAT with the Becton Dickinson ProbeTec in detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal samples.
| Condition | Intervention |
|---|---|
|
Gonorrhea Chlamydia |
Other: Gen-Probe APTIMA Combo2 (AC2) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Validation Study of the Gen-Probe APTIMA Combo2 (AC2) for Detecting Chlamydia Trachomatis and Neisseria Gonorrhoeae in Rectal Samples. |
- Compare the sensitivity and specificity of the AC2 to ProbeTec and culture in detecting GC in rectal samples [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
- Compare the sensitivity and specificity of the AC2 to ProbeTec and as necessary, for discrepant results, to APTIMA CT assay in detecting CT in rectal samples [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
| Enrollment: | 500 |
| Study Start Date: | May 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
-
Other: Gen-Probe APTIMA Combo2 (AC2)
This research is being done to compare the results of tests for diagnosing sexually transmitted infections (STIs) from rectal samples. Specifically, this study will test for gonorrhea and Chlamydia from rectal samples and compare the results between standard culture and newer technology (nucleic acid amplification testing otherwise know as "NAAT") used to detect these infections. Gonorrhea and Chlamyia are STIs (infections you get from having sex with someone who is infected). Infections in the rectum may cause symptoms such as rectal discharge, itching and/or pain or may be asymptomatic (no symptoms present). Since these infections are sexually transmitted, it is important to have accurate tests to diagnose and treat these infections to prevent them from being passed onto a sexual partner.
NAAT has not been Food and Drug Administration (FDA) approved for use in diagnosing these infections in the rectum. The tests are approved to detect these infections from other sites (cervix and urine) and investigators believe that these tests will be very accurate in detecting these infections in the rectum as well. This study will validate the use of NAAT in rectal samples so that this technology can be used in our research laboratory for future studies that involve testing for STIs from the rectum.
There are times when people have signs of inflammation in the rectum (known as proctitis) and an infection or cause is not able to be identified. Investigators believe that this new technology (NAAT) may be able to find reasons (different bacteria) for infection that were not able to be identified with older testing methods. By participating in this study, one of the rectal swabs will also be tested for additional bacteria (called Mycoplasma and Trichomonas). Both of these organisms are sexually transmitted and may be important organisms in the cause of proctitis.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male and female subjects aged 18 and older
- Women or men who have a history of engaging in receptive anal intercourse
- Willing to provide written informed consent for participation in this study
Exclusion Criteria:
- Use of oral antibiotics in the past 7 days
- Use of rectal douche or other rectal product in the past 24 hours
Contacts and Locations| United States, Pennsylvania | |
| Magee-Womens Hospital of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Pittsburgh AIDS Center for Treatment (PACT) | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Sharon L Hillier, PhD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Sharon L. Hillier, PhD, Magee-Womens Hospital of UPMC |
| ClinicalTrials.gov Identifier: | NCT00827697 History of Changes |
| Other Study ID Numbers: | PRO08120504 |
| Study First Received: | January 21, 2009 |
| Last Updated: | March 2, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Gonorrhea Chlamydia Rectal |
Additional relevant MeSH terms:
|
Chlamydia Infections Gonorrhea Chlamydiaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial |
Sexually Transmitted Diseases Infection Genital Diseases, Male Genital Diseases, Female Neisseriaceae Infections |
ClinicalTrials.gov processed this record on May 19, 2013